LIVing Donor Allograft for Anterior Cruciate Ligament Reconstruction Study — LivD_ACLR  

ACL Clinical Trial

Official title: A Prospective Cohort Study of Skeletally Immature Patients Requiring Endoscopic Anterior Cruciate Ligament Reconstruction, Using Living Donor Hamstring Allograft From a Parent

Status Recruiting

Clinical Trial Summary

The Anterior Cruciate Ligament (ACL) is a major stabiliser of the knee. ACL rupture is being increasingly identified in children and skeletally immature patients. The current advice in younger patients is usually to undergo ACL reconstruction. The choice of an ideal graft in children is difficult

This study will use a technique involves the use of hamstring tendons from a living donor, where the adult (usually a parent) agrees to donate their hamstring tendons, which are dissected out of them and implanted into the child

Clinical Trial Description

The Anterior Cruciate Ligament (ACL) is a major stabiliser of the knee. ACL rupture is being increasingly identified in children and skeletally immature patients. Following rupture of this ligament, the current advice in younger patients is usually to undergo ACL reconstruction. Different tissue or materials can be used to reconstruct the ligament. In the majority of cases around the world, tendon material taken from somewhere else in the patient is preferred, particularly the hamstring or patellar tendons.

The choice of an ideal graft in children is difficult. Patients who have not fully grown have smaller tendons than adults, making them less suitable for use in reconstructive surgery. Another option for children's reconstructions is allograft - tendons taken from another human being. This has most commonly been from organ donation (taking tendons from a recently deceased individual) however the rerupture rate of allograft has been shown to be higher than in autograft (tendons taken from the patient themselves). The higher rate of rerupture may be related to the sterilising and storage processes of the harvested tendons.

This study will use a technique used by a leading hospital in Sydney, Australia, that sees and treats a large volume of these patients and has published good outcomes. The technique involves the use of hamstring tendons from a living donor, where the adult (usually a parent) agrees to donate their hamstring tendons, which are dissected out of them and implanted into the child. The technique has the advantage of leaving the child's own tendons intact, and having a larger sized tendon from a parent.

Patients & parents will be approached in clinic after MRI confirmation of an ACL rupture. If all inclusion and exclusion criteria have been passed and they consent to participate, screening documents & tests will be completed. The parent will undergo a hamstring tenotomy whilst the child is prepped for ACL reconstruction, then the hamstring donor graft will be inserted in the child patient, using the surgeon's routine fixation devices. All patients will be assessed for skeletal maturity prior to surgery and will be followed up for two years or until skeletal maturity, whichever happens latest. They will follow standard rehabilitation guidelines for paediatric patients at Maidstone & Tunbridge Wells National Health Service Trust (MTW NHS Trust) and be seen at set study intervals for clinical review, subjective and objective assessment. Any adverse events will be reported to the health regulation authority and Human Tissue Licence Authority. ;

Related Conditions & MeSH terms

• ACL

• NCT number: NCT05395767
• Study type: Interventional
• Source: Maidstone & Tunbridge Wells NHS Trust
• Contact: Helen Samuel, MSc
• Phone: 01892 635488
• Email: h.sankey@nhs.net
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2021
• Completion date: September 2028